Comparison of the Self-Expandable Intra-Annular Navitor Prosthesis with the Balloon-Expandable, Intra-Annular Sapien...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Prosthetic Heart Valves

Background:

• Transcatheter aortic valve implantation (TAVI) is a key treatment for aortic stenosis.
• Comparing novel self-expandable valves with existing balloon-expandable options is crucial for optimizing TAVI outcomes.

Purpose of the Study:

• To compare the short-term clinical outcomes of the Navitor (NAV) self-expandable valve and the Sapien 3 Ultra (S3U) balloon-expandable valve in TAVI.
• To assess hemodynamic performance and safety profiles of these two intra-annular TAVI devices.

Main Methods:

• A single-center study utilizing propensity score matching (1:2 ratio) of 153 patients (51 NAV, 102 S3U).
• Analysis of clinical outcomes at 30 days according to VARC-3 recommendations.
• Key variables included demographics, baseline valve characteristics, and comorbidities.

Main Results:

• The Navitor valve group demonstrated significantly lower mean and maximum transvalvular gradients post-TAVI (p < 0.001).
• Effective orifice area (EOA) was significantly larger with the Navitor valve (p < 0.001).
• Severe patient-prosthesis mismatch (PPM) was significantly lower with Navitor (7.8%) compared to Sapien 3 Ultra (14.7%) (p = 0.002).
• Rates of paravalvular regurgitation, stroke, bleeding, vascular complications, and pacemaker implantation were comparable between groups.
• 30-day mortality was low and similar between the two valve groups.

Conclusions:

• The self-expanding Navitor valve exhibits excellent acute safety and superior early hemodynamic performance compared to the Sapien 3 Ultra valve.
• Lower transvalvular gradients and reduced severe PPM were observed with the Navitor valve.
• Long-term clinical outcome benefits of these acute hemodynamic advantages require further investigation in long-term follow-up studies.